Evaluation of a New Software for Diagnosing Coronary Artery Disease Using Past CT Angiography Data Comparing Automated Detection and Analysis with Current Diagnostic Methods

What this Trial Is About

Researchers are evaluating a new diagnostic software application designed to assess coronary artery disease CAD using coronary computed tomography angiography CCTA images. This observational study aims to compare the softwares diagnostic accuracy and consistency with current clinical practices and expert evaluations. The software combines automated detection of artery narrowing, CT-derived fractional flow reserve CT-FFR, and plaque quantification to enhance CAD assessment. The study includes 1,000 patients who previously underwent CCTA between 2019 and 2024, with available comparator data such as invasive coronary angiography ICA, stress MRI, or other CCTA analyses. No interventions are performed instead, researchers analyze de-identified imaging data offline using the novel software. The focus is on evaluating how well the software classifies CAD severity, predicts the need for procedures like percutaneous coronary intervention PCI, and potentially reduces unnecessary invasive tests. Participants involvement is limited to the use of their existing imaging and diagnostic data collected during routine care. Researchers will assess diagnostic accuracy, reproducibility of CAD severity classification, user satisfaction with the software, and its ability to predict treatment needs. The study does not involve new procedures or treatments and aims to provide evidence for integrating advanced diagnostic tools into clinical practice by the studys end in 2027.

Evaluation of a Diagnostic Software for Coronary Artery Disease Using Retrospective CCTA Data (CODEX-1 Study)